Document is current

Article History

Received: 14 October 2020

Accepted: 16 October 2020

First Online: 28 October 2020

Ethics approval and consent to participate

: University of Maryland, Baltimore (UMB) Institutional Review Board (IRB) approved the the referenced protocol entitled, “2038GCCC: Randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19”. Approval for this project is valid from 4/30/2020 to 4/29/2021.The principal investigator and the corresponding author (AE) certifies that this trial has received ethical approval from the appropriate ethical committee as described above.Informed consent is a process that is initiated prior to the individual agreeing to participate in the study and continues throughout the individual’s study participation. The informed consent form is IRB-approved and the subject will be asked to read and review the document.Due to the excessive risk of COVID-19 transmission and to preserve limited personal protective equipment (PPE) for essential procedures, a remote consenting process can be used. The following considerations for remote informed consenting should be followed: The investigator and/or his designee is responsible for presenting the risks and benefits of study participation to the subject in simple terms using the informed consent document; Potential subjects will be given an informed consent form (either paper or electronic document in a portable electronic device) and allowed time to read this document; The elements of the informed consent, including discussion of the risk and benefits, will be done either over the phone or via remote video conferencing methods approved by the IRB; Research team member will document how the consent form was transmitted or given to participant, and what method was used to communicate the informed consent; The investigator will ensure that written informed consent is obtained from each subject or legally authorized representative by obtaining the appropriate signatures and dates on the informed consent document before the performance of protocol evaluations or procedures; Signatures may be obtained using the following options: (1) electronic signature, or (2) photograph of signature/signature page sent back to study team; Subjects must date the informed consent form to be valid; Study team member should document how signature was obtained.If unable to obtain a participant signature on an informed consent document, the following should be followed: Document the method used for communication with the patient; Document means by which agreement was communicated; Document that no imaging technology was available to capture a signed consent form; A witness to the process AND a witness to sign and date the informed consent form.Participants must be informed that participation is voluntary and that they may withdraw from the study at any time, without prejudice. Copies of the informed consent documents will be given to the participants for their records. The informed consent process will be conducted and documented in the source document (including the date) before the participant undergoes any study-specific procedures. The rights and welfare of the participants will be protected by emphasizing to them that the quality of their medical care will not be adversely affected if they decline to participate in this study.For patients who are too unwell to provide consent such as patients on invasive ventilator or ECMO, Legally Authorized Representative (LAR) can sign the informed consent.

: Not applicable.

: The authors declare that they have no competing interests.